Bimekizumab for psoriasis demonstrates safety, efficacy in phase 3 studies
Researchers at AAD VMX 2021 presented the results of the BE RADIANT study evaluating bimekizumab as a treatment for adults with moderate to severe plaque psoriasis, according to a UCB press release.
Bimekizumab is an investigational humanized monoclonal IgG1 antibody that inhibits IL-17A and IL-17F cytokines.
The New England Journal of Medicine published the results of the phase 3 BE SURE study, which evaluated the drug’s efficacy and safety profile compared with adalimumab, and the phase 3b BE RADIANT study, which compared the efficacy and safety of bimekizumab compared with secukinumab.
The BE SURE randomized double-blind study included 478 participants with at least 6 months of chronic plaque psoriasis affecting 10% or more of their body surface. The researchers conducted an active-controlled initial treatment period of 24 weeks followed by a dose-blind maintenance treatment period until week 56. The results demonstrated the safety profile of bimekizumab and its efficacy for superior levels of skin clearance at week 16 compared with adalimumab.
The BE RADIANT randomized multicenter double-blind study included 743 participants with at least 6 months of psoriasis affecting 10% or more of their body surface. The researchers randomly assigned patients to bimekizumab 320 mg every 4 weeks or secukinumab 300 mg weekly to week 4 and then every 4 weeks. Starting at week 16, patients taking bimekizumab received treatment every 4 or 8 weeks. Significantly more patients treated with bimekizumab achieved complete skin clearance starting at week 16 and continuing to the conclusion of the study at week 48.
“Data from this [BE RADIANT] study support the value of inhibition of IL-17F in addition to IL-17A in the treatment of patients with moderate to severe plaque psoriasis,” Kristian Reich, MD, PhD, of the Institute for Health Services Research in Dermatology and Nursing, University Medical Center Hamburg-Eppendorf, said in the release.
The FDA and European Medicines Agency are currently reviewing bimekizumab for the treatment of moderate to severe plaque psoriasis in adults. A Prescription Drug User Fee Act (PDUFA) date for bimekizumab has been set for Oct. 15, 2021 by the FDA.